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Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD

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ClinicalTrials.gov Identifier: NCT00585299
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : June 17, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University

Brief Summary:
To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will lead to improvements in insulin sensitivity, which will be associated with changes in both glucose status and lipid profiles, in obese children and adolescents with fatty liver who have normal glucose or pre-diabetes.

Condition or disease Intervention/treatment Phase
Fatty Liver Insulin Resistance Other: Low-fat diet Other: Traditional diet Not Applicable

Detailed Description:
This study will have two groups: one group that eats a moderate calorie, low-fat diet and is weighed regularly (every other week for 16 weeks) and the other who receives traditional diet therapy and returns in 16 weeks. Both groups will undergo procedures that test glucose tolerance and measure liver and muscle fat content before and after study period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
Study Start Date : October 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Low-fat diet
20% kcals from fat diet followed for 8 weeks then 8 weeks of maintenance diet with visits to dietitian every other week
Other: Low-fat diet
20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks

Other: Traditional diet
Traditional low-fat diet with dietitian follow-up in 16 weeks

Active Comparator: Traditional
Traditional low-fat diet given and dietitian follows up in 16 weeks
Other: Traditional diet
Traditional low-fat diet with dietitian follow-up in 16 weeks




Primary Outcome Measures :
  1. Liver Enzyme, liver and muscle fat content, glucose tolerance status [ Time Frame: 16-18 weeks ]

Secondary Outcome Measures :
  1. plasma lipid levels [ Time Frame: 16-18 weeks ]


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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 10 to 21 yrs of age
  • Non-smoking
  • BMI >95th percentile for age and gender, but BMI <40
  • Suspicion of fatty liver, with a high ALT (>35)
  • Normal glucose tolerance or prediabetes (impaired glucose tolerance or impaired fasting glucose)

Exclusion Criteria:

  • Females of child-bearing potential who are not using birth control
  • Pregnant or lactating females
  • Current medications except oral anti-diabetic medications and hormonal birth control
  • Lipid-lowering medication that increases liver enzymes
  • Significant kidney dysfunction (creatinine >1.5 mg/dL)
  • Current heavy ethanol use or recent history of binge drinking
  • History or evidence of hepatitis A, B, or C, Wilson's Disease, or alpha-1-antitrypsin deficiency
  • Known to be HIV positive
  • Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA classification as Functional Class III or IV
  • Major vascular event within 6 months of screening (e.g. MI, stroke)
  • Active cancer within 5 years prior to screening
  • Current systemic disease, including type 1 or 2 diabetes
  • Enrolled in another research study within 1 month prior to screening
  • Implanted paramagnetic material (all subjects will need to fill out the Yale Magnetic Resonance Center safety checklist)
  • Anemia (HCT <35%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585299


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Sonia Caprio, MD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00585299     History of Changes
Other Study ID Numbers: 0212023115
R01HD040787-01 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014

Keywords provided by Yale University:
steatosis
fatty liver
insulin sensitivity
fatty liver (steatosis)

Additional relevant MeSH terms:
Weight Loss
Hypersensitivity
Insulin Resistance
Fatty Liver
Body Weight Changes
Body Weight
Signs and Symptoms
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs